Clene Inc. · NASDAQ:CLNN
Clene — Technical Presentation (October 2021)
12 slides from Clene's technical presentation, Oct 14, 2021
Slide 1: Improvement of Brain Energy Metabolism in Relapsing MS: Phase 2 REPAIR-MS Results
Improvement of Brain Energy Metabolism in Relapsing Multiple Sclerosis: Results from Phase 2 REPAIR - MS Clinical Trial With CNM - Au8 Robert Glanzman 1 , Jimin Ren 2 , Austin Rynders 1 , Karen S. Ho 1 , Michael T. Hotchkin 1 Benjamin Greenberg 2 1 Clene Nanomedicine, Inc. Holladay, UT/United States
Slide 2: CNM-Au8: Energy Enhancing Nanotherapeutic
CNM - Au8® | Energy Enhancing Nanotherapeutic Improved Cellular Energy Production & Utilization E nergy Cellular > 100 Trillion Nanocrystals per 60 mL Dose (At 30mg) Oral Suspension; Once Daily 13 nm Median Diameter (Ribosome = 20 - 30 nm) Novel mechanism of action to address a range of CNS diseases
Slide 3: REPAIR Program: 31P MRS Imaging Modality at 7T
REPAIR Program | 31 P MRS Imaging Modality at 7T A T P - - P C r G P E G P C PC PE Pi in Pi ex - NAD UD PG Full Volume Coil Partial Volume Coil Pi in - intracellular inorganic phosphate Pi ex - extracellular inorganic phosphate PC - phosphocholine PE - phosphoethanolamine GPE - glycerophosphoe
Slide 4: REPAIR Study Design and Endpoints
• Difference in brain NAD+ and NADH fraction at Week 12 - 16 • Difference in bioenergetic metabolites (e . g . , ATP, PCr, NAD) concentration at Week 12 – 16 • Difference in brain membrane markers (PE, PC, etc.) at Week 12 – 16 Change in Brain Bioenergetic Potential (NAD+/NADH) vs. Baseline 1 ι 2 ι
Slide 5: Baseline Demographics & Treatment Baseline Values
REPAIR - MS | Baseline Demographics & Treatment 5 Ba s e li ne Values S u bje c ts n (%) Age [ y rs . ] mean (SD) Time from MS Onset [yrs.] mean (SD) EDSS m e an (SD) N ataliz um a b Treatment (%) All 13 (100%) 41.7 (10.0) 7.5 (5.2) 2.7 (1.9) 100% Female 9 40.9 6.9 2.8 100% (69%) (11.6) (4.4) (1.8)
Slide 6: Pre-specified Integrated Analysis (MS & PD Cohorts)
REPAIR Program Primary Endpoint Pre - specified Integrated Analysis (MS & PD Cohorts) CNM - Au8 Improved Brain Energy Metabolism (NAD + /NADH Ratio) 1 ƒ Endpoint 2 ƒ Endpoints 6
Slide 7: NAD+/NADH Ratio and % Fractions Relapsing MS Cohort
REPAIR - MS | NAD+/NADH Ratio and % Fractions Relapsing MS Cohort 1 ƒ Endpoint 2 ƒ Endpoints 7
Slide 8: NAD+/NADH Returned to Baseline Levels Post-Treatment
REPAIR - MS | NAD + /NADH Returned to Baseline Levels at 6 - Week Post - Treatment 8
Slide 9: CNM-Au8 Normalized Key Markers of Brain Metabolism in MS Patients
REPAIR - MS | CNM - Au8 Normalized Key Markers of Brain Metabolism in MS Patients [Exploratory] 9
Slide 10: LCLA Change from Baseline and Correlation by Eye
REPAIR - MS | LCLA Change from BL All Eyes & End of Treatment Correlation by Eye [Exploratory] 10
Slide 11: Safety Summary
REPAIR - MS | Safety Summary 11 • Treatment - emergent AEs were predominantly mild & transient • No serious adverse events • No subjects with treatment related clinically significant laboratory abnormalities
Slide 12: Results & Conclusions
REPAIR - MS | Results & Conclusions 12 • Statistically significant increase in NAD + /NADH ratio based on pre - specified integrated analyses of PD & MS cohorts • MS population trend in brain NAD + /NADH ratio improvement driven by increased NAD + and decreased NADH • Treatment normalized key marker